Australia - English - Department of Health (Therapeutic Goods Administration)

teva pharma australia pty ltd - sugammadex sodium, quantity: 217.6 mg (equivalent: sugammadex, qty 200 mg) - injection, solution - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - reversal of neuromuscular blockade induced by rocuronium or vecuronium in patients 2 years of age and older.

Australia - English - Department of Health (Therapeutic Goods Administration)

arrotex pharmaceuticals pty ltd - topiramate, quantity: 200 mg - tablet, film coated - excipient ingredients: croscarmellose sodium; macrogol 8000; titanium dioxide; magnesium stearate; iron oxide red; colloidal anhydrous silica; methylcellulose; hyprolose; hypromellose - epilepsy. adults and children 2 years and over: as monotherapy in patients with newly diagnosed epilepsy; for conversion to monotherapy in patients with epilepsy; as add-on therapy in partial onset seizures (with or without secondary generalised seizures), primary generalised tonic-clonic seizures or drop attacks associated with lennox-gastaut syndrome. migraine. prophylaxis of migraine headache in adults.

Australia - English - Department of Health (Therapeutic Goods Administration)

viatris pty ltd - trandolapril, quantity: 4 mg; verapamil hydrochloride, quantity: 240 mg - tablet, film coated - excipient ingredients: maize starch; lactose monohydrate; povidone; hypromellose; sodium stearylfumarate; microcrystalline cellulose; sodium alginate; magnesium stearate; hyprolose; macrogol 400; macrogol 6000; purified talc; colloidal anhydrous silica; titanium dioxide; iron oxide red; iron oxide yellow; iron oxide black; docusate sodium - tarka is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - isavuconazonium sulfate, quantity: 186.3 mg (equivalent: isavuconazole, qty 100 mg) - capsule - excipient ingredients: potassium acetate; gellan gum; iron oxide red; sodium lauryl sulfate; titanium dioxide; hypromellose; disodium edetate; magnesium citrate; microcrystalline cellulose; purified talc; colloidal anhydrous silica; stearic acid; propylene glycol; butan-1-ol; purified water; isopropyl alcohol; shellac; strong ammonia solution; ethanol absolute; iron oxide black; potassium hydroxide - cresemba is indicated in adults for the treatment of ? invasive aspergillosis ? mucormycosis in patients for whom amphotericin b is inappropriate (see section 4.4 special warnings and precautions for use and section 5.1 pharmacodynamic properties),consideration should be given to official guidance on the appropriate use of antifungal agents.

Australia - English - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - risperidone, quantity: 0.5 mg - tablet, film coated - excipient ingredients: sodium lauryl sulfate; lactose monohydrate; pregelatinised maize starch; colloidal anhydrous silica; magnesium stearate; microcrystalline cellulose; titanium dioxide; hypromellose; propylene glycol; purified talc; iron oxide red; iron oxide black - rixadone is indicated for - the treatment of schizophrenia and related psychoses.,- the short term treatment of acute mania associated with bipolar 1 disorder (see dosage and administration: bipolar mania).,-the treatment (up to 12 weeks) of psychotic symptoms, or persistent agitation or aggression unresponsive to non-pharmacological approaches in patients with moderate to severe dementia of the alzheimer type. (see dosage and administration: behavioural disturbances in dementia).,- the treatment of conduct and other disruptive behaviour disorders in children (over 5 years), adolescents and adults with sub-average intellectual functioning or mental retardation in whom destructive behaviours (e.g. aggression, impulsivity and self-injurious behaviours) are prominent (see clinical trials for maintenance data).,- the treatment of behavioural disorders associated with autism in children and adolescents (see clinical trials).

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - enalapril maleate, quantity: 10 mg - tablet, uncoated - excipient ingredients: maize starch; sodium bicarbonate; lactose monohydrate; iron oxide red; purified talc; magnesium stearate - indications: hypertension. all grades of essential hypertension; renovascular hypertension. congestive heart failure. treatment of all degrees of symptomatic heart failure. in such patients it is recommended that enalapril sandoz be administered together with a diuretic. left ventricular dysfunction. all degrees of left ventricular dysfunction where the left ventricular ejection fraction is less than 35%, irrespective of the presence or severity of obvious symptoms of heart failure.

Australia - English - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - rifabutin, quantity: 150 mg - capsule, hard - excipient ingredients: microcrystalline cellulose; sodium lauryl sulfate; magnesium stearate; silicon dioxide; iron oxide red; titanium dioxide; gelatin; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; simethicone; ethanol; shellac; sulfuric acid; povidone; tert-butyl alcohol; sodium hydroxide - mycobutin is indicated for: the prophylaxis of m.avium-intracellulare complex (mac) infections in patients with advanced hiv infection (cd4 counts lower than 200/ul); the treatment of infections caused by mac and other atypical mycobacteria, including in immunocompromised patients; the treatment of chronic multi-drug resistant pulmonary tuberculosis in the presence of rifampicin resistant, rifabutin-sensitive m.tuberculosis strains; the treatment of newly diagnosed pulmonary tuberculosis in the presence of rifampicin resistant, rifabutin sensitive m.tuberculosis strains. in accordance with the commonly accepted criteria for the treatment of mycobacterial infections, mycobutin should always be given in combination with other anti-mycobacterial drugs not belonging to the family of rifamycins.

Australia - English - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - pirfenidone, quantity: 801 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; colloidal anhydrous silica; povidone; croscarmellose sodium; magnesium stearate; polyvinyl alcohol; titanium dioxide; macrogol 3350; purified talc; iron oxide red; iron oxide black - esbriet is indicated for the treatment of idiopathic pulmonary fibrosis (ipf).

Australia - English - Department of Health (Therapeutic Goods Administration)

takeda pharmaceuticals australia pty ltd - mesalazine, quantity: 1200 mg - tablet, modified release - excipient ingredients: methacrylic acid copolymer; purified talc; silicon dioxide; sodium starch glycollate; stearic acid; iron oxide red; carmellose sodium; carnauba wax; magnesium stearate; titanium dioxide; macrogol 6000; triethyl citrate - for the induction and maintenance of remission in patients with mild to moderate, active ulcerative colitis.

Australia - English - Department of Health (Therapeutic Goods Administration)

cipla australia pty ltd - imatinib mesilate, quantity: 478 mg (equivalent: imatinib, qty 400 mg) - capsule - excipient ingredients: magnesium stearate; lactose; colloidal anhydrous silica; crospovidone; titanium dioxide; purified water; iron oxide yellow; iron oxide red; gelatin; sodium lauryl sulfate - imatinib gh is indicated for the: ? treatment of patients with chronic myeloid leukaemia (cml) ? treatment of adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy ? treatment of adult patients with relapsed or refractory ph+ all as monotherapy ? treatment of adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements, where conventional therapies have failed ? treatment of adult patients with aggressive systemic mastocytosis (asm), where conventional therapies have failed ? treatment of adult patients with hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) ? adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (dfsp).